Kornimate/medical-research-clean huggingface dataset:
vivity outcomes in patients with early stage glaucoma

Conditions: Glaucoma; Cataract; Presbyopia

Summary: the goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the alcon vivity extended range intraocular lens (iol).


Eligibility criteria:
inclusion criteria: 1. patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (migs) 2. subjects with documented diagnosis of pre-perimetric glaucoma 3. calculated lens power within vivity/vivity toric range 4. willing and able to comprehend informed consent and complete 4-6 month post-op visit 5. potential postoperative bcdva of 20/20 or better in each eye based on investigator's medical opinion exclusion criteria: 1. ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative bcdva 2. previous ocular surgery including refractive surgery 3. subjects who are pregnant or plan to become pregnant during the course of the study.

Keywords: extended range of vision, intraocular lens technology, glaucoma
a comparative study of endoscopic submucosal dissection and photodynamic therapy for early esophageal cancer

Conditions: Esophageal Carcinoma in Situ AJCC V7

Summary: the purpose of this study was to compare the efficacy and safety of photodynamic therapy (pdt) and endoscopic submucosal (esd) dissection in the treatment of early esophageal cancer.

background: photodynamic therapy (pdt) is recommended by the nccn guidelines as an effective method for the treatment of early esophageal cancer. however, there is no clinical trial data so far on whether its efficacy can be compared with that of standard endoscopic submucosal (esd). our team will conduct a detailed study on it. aim: to compare the efficacy and safety of photodynamic therapy (pdt) and endoscopic submucosal (esd) dissection in the treatment of early esophageal cancer. methods: this study intends to recruit 46 patients with early esophageal cancer and randomly divide them into two groups: one group to receive esd and the other group to receive pdt.the efficacy and safety were observed after 2 years of follow-up. primary endpoints: the recurrence rates at 3 months, 6 months, and 2 years were compared.

Eligibility criteria:
inclusion criteria: * high-grade intraepithelial neoplasia of the esophagus * 18-80 years old * the tumor was confined to the lamina propria of the mucosa * the tumor invaded the submucosa and was limited to 200 microns exclusion criteria: * the tumor invaded the entire circumference of the esophagus * the tumor invaded the muscularis or submucosa more than 200 microns * the patient has difficulty tolerating anesthesia due to other diseases * pregnant or breastfeeding women

Keywords: early esophageal carcinoma photodynamics therapy endoscopic submucosal dissection
the immune landscape of epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: this is a single center prospective observational study to characterize the immune landscape of newly diagnosed epithelial ovarian cancer (oc). patients with newly diagnosed epithelial oc will be enrolled in 4 different cohorts: a) newly diagnosed high grade serous or endometroid oc undergoing primary debulking surgery; b) newly diagnosed high grade serous or endometroid oc undergoing neoadjuvant chemotherapy (nact) followed by interval debulking surgery; c) rare subtypes of epithelial oc (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery; d) rare subtypes of epithelial oc (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing nact followed by interval debulking surgery. a cohort of women undergoing adnexectomy for benign pathology will be enrolled (cohort e) for comparative analysis. enrolled patients will be asked to provide the following biological samples at specified time points: archival and fresh tumor tissue, peripheral blood samples, rectal and vaginal swabs, ascites (when present). the main aim of the study is to characterize the immune landscape of epithelial oc in tumor tissue and peripheral blood and correlate the presence of myeloid-derived suppressive cells (mdscs) and other immune infiltrates and of the systemic immune response with progression free interval (pfi) in epithelial oc.


Eligibility criteria:
inclusion criteria cohort a-d: * suspicious diagnosis of epithelial ovarian cancer (subsequent histologically confirmation required) * plan to undergo a surgical procedure for the management of epithelial ovarian cancer or recurrent ovarian cancer previously treated with conventional treatment and involved in the trial as group a-d * ≥18 years old * ecog performance status ≤ 2 * written informed consent inclusion criteria cohort e: * indication for adnexectomy for a benign gynecological condition * ≥18 years old * ecog performance status ≤ 2 * written informed consent exclusion criteria cohort a-e: * other active concomitant neoplasms that might confound the results of the planned analysis. * ongoing active autoimmune disease requiring treatment or condition of immune deficiency * ongoing chronic treatment with steroids or other immune suppressive agents at the time of study entry
ethicon pelvic mesh post market clinical follow-up registry

Conditions: Stress Urinary Incontinence; Pelvic Organ Prolapse

Summary: the objective of this post market, clinical registry is to evaluate the performance of the products of the tvt family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either gynemesh ps mesh or artisyn mesh in women undergoing surgery for sui and pop.


Eligibility criteria:
inclusion criteria: patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry: sui 1. stress urinary incontinence symptoms 2. urodynamic stress incontinence confirmed with urodynamic testing 3. female patient ≥ 21 years of age 4. desired surgical correction of sui using synthetic pubo-urethral vaginal sling 5. planned surgery for primary sui 6. patient able and willing to participate in follow-up 7. patient or authorized representative has signed the approved informed consent pop 1. uterine or vaginal vault prolapse symptoms 2. urodynamic testing (optional) 3. female patient ≥ 21 years of age 4. desired surgical correction of pop using synthetic mesh 5. planned surgery for uterine or vaginal vault prolapse with or without concomitant sui surgery 6. patient able and willing to participate in follow-up 7. patient or authorized representative has signed the approved informed consent exclusion criteria patients meeting any of the following criteria will be considered not eligible for enrollment in this registry: 1. physical or psychological condition which would impair registry participation or are unwilling or unable to participate in all required registry visits and are unable to complete the questionnaires 2. any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products 3. history of previous synthetic, biologic or fascial sub-urethral sling (sui) or pelvic mesh (pop) 4. pregnancy or plans for future pregnancy 5. history of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice 6. current genitourinary fistula or urethral diverticulum 7. reversible cause of incontinence (i.e. drug effect) for sui only 8. severe vaginal atrophy 9. history of pelvic irradiation therapy 10. contraindication to surgery

Keywords: stress urinary incontinence pelvic organ prolapse sui pop
long-term outcomes of different stents for benign biliary strictures caused by chronic pancreatitis

Conditions: Chronic Pancreatitis; Benign Biliary Strictures; Stenting Treatment; ERCP; ESWL

Summary: this observational study aims to observe and compare the long-term effectiveness and safety of different types of stents for benign biliary strictures secondary to chronic pancreatitis.

chronic pancreatitis (cp) is a debilitating condition that often results in the development of benign biliary strictures (bbs), which significantly contribute to morbidity. bbs are prevalent among a substantial number of cp patients, causing complications such as cholestasis and jaundice. endoscopic biliary stenting has traditionally been the primary treatment for bbs, initially employing single plastic stents (sps), which yielded suboptimal outcomes. nowadays, fully covered self-expanding metal stents (fcsems) and multiple plastic stents (mps) are considered the first line therapies for bbs caused by cp. however, advancements in lithotripsy and endoscopic retrograde cholangiopancreatography have led to a marked increase in the successful rate of pancreatic duct decompression. this progress necessitates a reevaluation of the effectiveness of sps. the objective of this study is to assess and compare the long-term outcomes of various stenting types in patients with bbs due to cp. it is expected that the study's results will provide valuable insights into the optimal stenting strategies for bbs in cp patients. these insights have the potential to greatly influence clinical practice and guide the development of treatment guidelines.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic pancreatitis * benign biliary strictures secondary to chronic pancreatitis * patients who have undergone endoscopic biliary stenting for the management of bbs between january 2011 and december 2021. * complete treatment records exclusion criteria: * patients diagnosed with pancreatic cancer within two years following the diagnosis of cp. * incomplete records of endoscopic biliary stenting treatment

Keywords: benign biliary strictures biliary stenting chronic pancreatitis plastic stents self-expandable metallic stents
adolescents' response to hepatitis b vaccine booster dose

Conditions: Hepatitis B

Summary: the aims of this study are to determine: 1. the degree of immunity against hepatitis b, 2. factors associated with immunity against hepatitis b, 3. if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and 4. if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis b among adolescents 16-19 years of age born in the united states who were immunized against hepatitis b as infants. these data will be important to evaluate the potential need for a possible booster dose of hepatitis b vaccine among adolescents. study subjects eligible for enrollment will: * have blood drawn for baseline serologies * receive the hepatitis b booster dose (randomly determined to be either a 10 ug or 20 ug dose) * have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine) the primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis b in response to a booster dose of vaccine.


Eligibility criteria:
inclusion criteria: * 16-19 years of age * born in the united states * received the full hepatitis b vaccination series by 12 months of age * received the third dose of hepatitis b vaccine within 10 months of the first dose exclusion criteria: * a history of hepatitis b disease * being born to a mother with hepatitis b at the time of the participant's birth * having received hepatitis b immune globulin as an infant * immunosuppression including hiv or chronic/current steroid use (use \> 10 days duration within the 3 months of enrollment) * renal insufficiency or dialysis * pregnancy (due to theoretical risk of different immune response among pregnant females) * ever receiving a booster (fourth) dose of hepatitis b vaccine * history of allergy to the hepatitis b vaccine * receipt of blood products or igg within 3 months of enrollment * having received another vaccine within 2 weeks of enrollment

Keywords: hepatitis b vaccine duration of protection adolescent immunization anamnestic response booster dose immunity to hepatitis b as measured by anti-hbsag titers
israel multicenter d-serine study (imser) for the treatment of schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the goal of the present study is to evaluate the effect of d-serine, added to antipsychotic treatment, on negative and cognitive symptoms in schizophrenia. the investigators are hypothesizing that d-serine will improve cognitive functioning and negative symptoms.


Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual of mental disorders - fourth edition (dsm-iv) diagnosis of schizophrenia and\\or schizoaffective disorder. * age between 18 to 64. * panss negative symptom score higher than 19. * sas total score lower than 12. * cdss suicidal risk lower than 2 exclusion criteria: * epilepsy * meets dsm-iv criteria for mental retardation. * medical condition which confounds presentation or treatment (e.g. uncontrolled diabetes mellitus, history of kidney stones, acute drug toxicity, dementia, delirium, stroke, etc.) * meets dsm-iv criteria for alcohol or drug dependence in last 6 months. * meets dsm-iv criteria for alcohol or drug abuse in last one month. * treatment with clozapine. * current positive pregnancy test or not using acceptable method of birth control. * meets dsm-iv criteria for current anxiety or mood disorders

Keywords: d-serine negative symptoms cognition schizophrenia amino acid
nutritional education for dependant patients

Conditions: Risk of Malnutrition

Summary: objective: to assess the effect of a nutritional educational intervention on the risk of malnutrition dependent patients aimed at the caregivers. material and methods: intervention study with control group, with 200 patients randomized selected, in a home care program of 5 primary care centers, malnourished and dependents, older than 65 years and with a caregiver. socioeconomic and cultural characteristics of the patient and the caregiver are collected. mini nutritional assessment (mna), food intake, anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, hemoglobin, lymphocyte count, iron, ferritin, are evaluates on 0- 6-12 months. also evaluated dentures, basic activities of daily living (barthel test), cognitive state (pfeiffer test) status of mood (yesavage test). prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. the nurses make an initial session for caregivers and monitored the education at home monthly (4 visits) up to 6 months. nanda (north american nursing diagnosis association) specific methodology of the nursing profession is used. the investigators studied the effect of the intervention on the caregivers on the patient's nutritional status by the mna test, diet, anthropometry and biochemical parameters. bivariate normal test statistics and multivariate models were created to adjust the effect of the intervention. the program spss / pc was used.


Eligibility criteria:
inclusion criteria: * be included in the program atdom, * 65 years or more, * have an mna between 17 and 23.5 points, * have a caregiver. exclusion criteria: * have a mna outside the range of 17 to 23.5 points, * conducting enteral feeding * have severe dysphagia, * have any serious illness that progresses to malnutrition, * take vitamin supplements and / or dietary supplements.

Keywords: nutritional status dependent patients nutritional educational intervention caregivers clinical assay
prospective observational study of febrile neutropenia (fn) and pegfilgrastim primary prophylaxis in breast cancer and non-hodgkin's lymphoma patients receiving high (>20%) fn-risk chemotherapy

Conditions: Chemotherapy-induced Febrile Neutropenia

Summary: to estimate the incidence of febrile neutropenia in patients with breast cancer and non-hodgkin's lymphoma receiving high (\> 20%) fn-risk chemotherapy and pegfilgrastim primary prophylaxis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * any stage nhl or breast cancer and received the first cycle of a new chemotherapy course. * received the first cycle of a permitted standard dose chemotherapy regimens with an estimated high (\> 20%) fn risk according to published data or guidelines (dose modifications +/-10% in cycle 1 are allowable). * initiated treatment in cycle 1 with pegfilgrastim according to the pegfilgrastim summary of product characteristics. (smpc). enrolment must occur after the first pegfilgrastim dosing in cycle 1 and before the second day of cycle 2. exclusion criteria: * ongoing or planned concurrent participation in any clinical study involving investigational product that has not been approved by the national competent authorities for any indication. * ongoing or planned concurrent participation in any clinical study where the administration of colony stimulating factor (csf) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated).

Keywords: nhl breast cancer
changes in velocimetric indices of uterine and umbilical arteries before and after combined spinal-epidural analgesia in laboring women (part ii)

Conditions: Labor Pain

Summary: combined spinal-epidural (cse) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. cse is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following cse. this is self-resolving with minimal or no intervention. although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. similar mechanism is thought to be a cause of fetal bradycardia after the cse with its faster onset and superior block. maternal or fetal circulation during labor can be assessed using continuous-wave doppler ultrasound to monitor maternal uterine artery (uta) and fetal umbilical artery (uma) velocity waveforms to detect changes in blood flow. the velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of cse. thus, the aim of this study is to investigate the impact of cse to maternal and fetal blood flow to evaluate the relationships. the investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of cse, which may be responsible for the occurrence of fetal bradycardia.


Eligibility criteria:
inclusion criteria: * written informed consent * term pregnant patients requesting labor analgesia * singleton pregnancy * term pregnant patients in active labor * asa\<4 * no evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to cse * patients with and without diagnosed hypertensive disorders of pregnancy exclusion criteria: * refusal to consent for the study * known spinal deformities * previous back instrumentation * patients with bmi\>50 kg/㎡ due to anticipated technical challenges in doppler studies

Keywords: combined spinal epidural (cse) fetal bradycardia ultrasound velocimetric index hypertension
standard chemotherapy with of without axitinib in malignant mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: the purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma

to determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (mvd): expression of vegf-receptor; pdgf receptor expression; extent of necrosis and apoptosis. to determine the safety of the addition of axitinib (to a maximum of the recommended dose of maximally 2 x 10 mg per day) to the standard treatment with cisplatin and pemetrexed. to determine the feasibility of performing a (second) thoracoscopy after 10 weeks of the combination treatment with cisplatin, pemetrexed and axitinib. serum samples will be collected and tested for inhibiting effects in a tube formation and spheroid sprouting assay.

Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosed malignant mesothelioma * age \> 18 years * medically suitable for limited surgical intervention (pleural biopsies or limited pleurectomy) * measurable or evaluable disease is not required * ability to understand the study and give signed informed consent including the approval to accept a second thoracoscopic or surgical treatment after the third course * no previous chemotherapy * radiotherapy is allowed when this is given for palliation, the interval is \> 4 weeks, not more than 1/3 of the bone marrow capacity or all tumor is within the irradiation field. * who performance status =\< 2 * adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry: hematology: * anc=\>1.5 x 109/l, * platelets=\>150 x 109/l, * hemoglobin =\> 6,0 mmol/l chemistry: * total serum bilirubin \< unl; * ast and alt= \< 2.5xunl, * ap \< 5xunl (unless bone metastases are present in the absence or any liver disease) * serum creatinine =\< 2xunl exclusion criteria: * active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency * previous successful pleurodesis * uncontrolled hypertension * symptomatic peripheral neuropathy =\> grade 2 according to ncic ctc,version 3.0 * presence of symptomatic cns metastases * unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition * concomitant administration to any other experimental drugs under investigation * impaired renal function

Keywords: mesothelioma chemotherapy translational research axitinib